Armenia Pharmaceutical Serialization and Traceability Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

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Lot Level Traceability

Products are traceable as part of uniquely identified lots.

Summary

Armenia has implemented pharmaceutical serialization requirements to strengthen medicine safety and improve supply chain transparency. The framework is overseen by the Ministry of Health of the Republic of Armenia and the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE).

The system requires unique identification of pharmaceutical products using standardized barcode technology and electronic reporting of serialized product data. Serialization allows regulators and supply chain participants to verify medicine authenticity and monitor product movement across the distribution chain.

Manufacturers, importers, wholesalers, and pharmacies must ensure serialized identification of pharmaceutical products placed on the Armenian market and maintain traceability records throughout the supply chain.

Labelling Requirements 

Pharmaceutical products distributed in Armenia must include a GS1 compliant 2D DataMatrix barcode on the secondary packaging.

The barcode must contain the following data elements:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

Each sellable pack must have a unique serial number generated during packaging operations.

Human readable information printed on the packaging must match the encoded barcode data.

The barcode enables verification of individual pharmaceutical packs and supports traceability throughout the supply chain.

Regulatory Timeline 

  • 2017 – Armenia begins implementing pharmaceutical serialization requirements to improve supply chain transparency.
  • 2018 – Regulatory framework established for medicine identification and electronic reporting.
  • 2020 onward – Supply chain participants required to comply with serialization and reporting requirements for medicines placed on the market.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial Number, Batch, Expiry
During packaging before product release
Serialization Upload
Serialized pack data
Before product distribution in Armenia
Import Reporting
Serialized pack information and shipment data
Before import clearance
Shipment
Sender and receiver identifiers with serialized pack list
Before dispatch
Receiving
Serialized pack verification
Upon receipt of product
Dispensing
Serial number verification and status update
When supplied to patient
Decommission
Serial number and status change
When product is dispensed, destroyed, or removed

Operational Timelines for Industry 

  • Generate unique serial numbers for each pharmaceutical pack during packaging operations.
  • Print GS1 compliant DataMatrix barcodes on the secondary packaging of each product.
  • Upload serialized pack information to the national reporting system before products are distributed.
  • Report import and shipment transactions when products enter the Armenian market.
  • Maintain traceability records across manufacturers, importers, wholesalers, and pharmacies.
  • Verify serialized medicines during distribution and dispensing operations.
  • Provide traceability information during regulatory inspections or product recall investigations.

Reporting Hub

  • Armenia operates a national medicine verification platform managed by regulatory authorities responsible for pharmaceutical oversight.
  • Manufacturers and importers submit serialization data to the national system to enable verification of medicines placed on the Armenian market.
  • Supply chain participants can verify serialized medicines during distribution and dispensing activities. The system supports regulatory monitoring, product authentication, and investigation of suspicious medicines.
  • Electronic reporting is typically performed through integrated systems or secure regulatory portals.

Aggregation Requirements 

  • The Armenian serialization framework primarily focuses on pack level serialization and verification.
  • Aggregation hierarchies linking individual packs to cases or pallets are not mandated at the national regulatory level.
  • Manufacturers and distributors may implement aggregation internally to improve logistics efficiency and warehouse management.
  • Logistics units may use SSCC identifiers to support shipment tracking across supply chain operations.

Common Errors to Avoid 

  • Failure to upload serialization data before distributing medicines in Armenia.
  • Mismatch between printed barcode information and reported serialization data.
  • Duplicate serial numbers generated during packaging operations.
  • Incomplete reporting of shipment or import transactions.
  • Failure to maintain traceability records needed for product recalls or regulatory inspections.
  • Poor barcode print quality that prevents reliable scanning during supply chain operations.

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LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful

Hussein Salman
Lead Pharmacist, Pioneer Pharmacy Services

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EPCIS Data Encoder,Capital Wholesale Drug
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